Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A)
FDA premarket approval P860022/S061 · decided 2025-12-16
Approval details
- PMA number
- P860022
- Supplement
- S061
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A)
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Bausch & Lomb
- Date received
- 2025-11-13
- Decision date
- 2025-12-16
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- installation and validation of two Large Diameter (Scleral) Lathes at the Bausch + Lomb facility located in Wilmington, MA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Stellaris Elite vision enhancement system (K170052) | Bausch+Lomb | 2017-04-19 |
| Stellaris Elite Vision Enhancement System (K162342) | Bausch+Lomb | 2017-03-24 |
| STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486) | Bausch & Lomb | 2014-03-12 |
| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
| BAUSCH & LOMB INJECTOR SYSTEM (K131958) | Bausch & Lomb | 2014-01-09 |
| BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (K133146) | Bausch & Lomb | 2014-01-03 |
| EASY-LOAD LENS DELIVERY SYSTEM (K132481) | Bausch & Lomb | 2013-12-27 |
| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |